PRODUCT CODE BC VERSION NUMBER SPECIFICATION

Transcription

1 1. SPECIFICATION Product Description: β-carotene powder 10% TAB is a red or red-brown powder, with white spots of food starch.manufactured by spray drying adopting the advanced microencapsulation technology. The individual particles containing β-carotene are finely dispersed in gelatin-coated carbohydrates. Ascorbyl palmitate and dl-α-tocopherol are added as antioxidants. As a nutrient for tablet, hard-shell capsule preparations. Chemical structure: Specifications: Chemical Formula : C 40 H 56 Molecular Weight : g/mol Description red or red-brown powder, with white spots of food starch Lose on drying 8.0% Heavy metals(as Pb) 0.002% Arsenic % Particle Size <# 20 US 100% <# 40 US 85% <# 100 US 15% Assay Microbial test Bacteria Fungi and yeasts Enterobacteriaceae 10.0% 1000cfu/g 100cfu/g <30 MPN/100g Storage: Package: The product may be stored for 18 months from the date of manufacture in the unopened original container. Keep container tightly closed under cool and light proof conditions. Once opened, use contents quickly. 5kg/ Aluminium Bag, 20kg/Carton.

2 2.FLOW CHART β-carotene vitamin E Ascorbyl palmitate gelatin water sugar dissolving dissolving oil phase filtrate aqueous phase emulsification starch spray granulation fluidized granulation sieving sampling packing storage

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4 3. INGREDIENTS SHEET β-carotene Pure 10.0% Sugar 32.0% Corn Starch 18.0% Ascorbyl Palmitate 2.0% Gelatin 36.0% Vitamin E 2.0%

5 4. NUTRITION FACTS

6 Energy (kj) Protein (g/100g) Carbohydrate (g/100g) Of which sugars / Fat Of which saturates 1.88 Dietary Fibre Sodium (g/100g) (Declare to 3 decimal places) Moisture (g/100g) / Ash (g/100g) / Glucose (g/100g) / Fructose (g/100g) / Sucrose (g/100g) / Lactose (g/100g) / Alcohol % v/v / Potassium (mg/100g) 7.06 Calcium (mg/100g) 9.64 Zinc (mg/100g) Magnesium (mg/100g) 1.72 Acidity Level % / ph /

7 5. MSDS 1. Identification of the substance/preparation and of the company Identification of the product Product name:β-carotene Powder 10% TAB Manufacturer/supplier identification Manufacturer: Zhejiang Medicine Co.,ltd., Xinchang Pharmaceutical Factory Emergency Phone: Composition/information on ingredients β-carotene Gelatin Corn Starch Synonyms β-carotene CAS-No Chemical Formula C 40 H 56 Molecular Weight: g/mol Ascorbyl Palmitate Vitamin E Sugar 3. Hazards identification Most important hazards - No particular hazards known. 4. First-aid measures Skin contact:brush off Eye contact:rinse immediately with tap water for 10 minutes - open eyelids forcibly Inhalation:remove the casualty to fresh air and keep him/her calm- consult physician Note to physician: treat symptomatically 5. Fire-fighting measures Suitable extinguishing media: water spray, dry chemical, foam, CO 2 Specific hazards: consider dust explosion hazard- formation of acrid smoke and respiratory irritant fumes when heated to decomposition Protection of fire-fighters: precipitate gases/vapours/mists with water spray

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9 MSDS 6. Accidental release measures Environmental protection - do not allow to enter drains or waterways *1 - nontoxic and biodegradable, but very slow biodegradation due to low water solubility *1 - strong dyeing effect *1 Methods for cleaning up - collect solids (avoid dust formation) and hand over to waste removal 7. Handling and storage Handling Technical measures - processing in closed systems - avoid dust formation; consider dust explosion hazard - take precautionary measures against electrostatic charging - local exhaust ventilation necessary Suitable materials Storage - stainless steel, aluminium, glass, polyethylene, enamel Storage conditions - cool - protected from light - protected from humidity Validity - 18 months, 5 to 15 C, in the unopened original container, see"best use before" date stated on the label, after opening the container, the contents should be used within a short period Packaging materials - tightly closing; material: stainless steel, aluminium, glass, polyethylene 8. Exposure controls/personal protection Respiratory protection -respiratory protection not necessary during normal operations- in case of very Hand protection Eye protection high dust concentrations: particle mask or respirator with independent air supply - protective gloves - safety glasses Remarks - strong skin discolouration on contact *1

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11 9. Physical and chemical properties Colour - red to red-brown powder Form Odour Solubility - fine powder - none to faint MSDS - dispersible, cold water (20 C) Note - in aqueous dispersion yellow 10. Stability and reactivity Stability - stable under the conditions mentioned in chapter 7 Conditions to avoid Materials to avoid - air - warming - light - humidity - atmospheric oxygen, oxidizing agents, strong acids, strong bases, reducing agents, metal salts, compounds rich in oxygen *1 Note - autooxidation in the presence of atmospheric oxygen *1 11. Toxicological information Acute toxicity -LD50 > mg/kg (oral, rat) *1 - LD50> mg/kg (oral, mouse) *1 - LD50> mg/kg (oral, rat) *2 - LD50 > mg/kg (oral, mouse) *3 Mutagenicity -not mutagenic (various in vivo and in vitro test systems) * 1 Carcinogenicity -not carcinogenic (several species) *1 Reproduction toxicity - not teratogenic, not embryotoxic (several species) *1 Note -carotene is metabolised to vitamin A only in the physiologically required quantities (man); there areno indications of teratogenic effects nor reservations regarding hypervitaminosis A *1 - GRAS (generally recognized as safe for human consumption) *1 - GRAS (generally recognized as safe for human consumption) *2 - GRAS (generally recognized as safe for human consumption) *3 - GRAS (generally recognized as safe for human consumption) *5 - foodstuff, harmless at normal use *4 no toxic effects have been observed during occupational handling

12 MSDS 12. Ecological information Inherent biodegradability - inherently biodegradable Ecotoxicity slow biodegradation due to low water solubility100 %, 28 d (MITI Test II, OECD No. 302 C) *1 -barely toxic for fish (rainbow trout) (MITI Test II, OECD No. 302C) *1 Air pollution Note NOEL 1000 mg/l *1 -barely toxic for microorganisms (activated sludge) NOEL (28 days) 30 mg/l - observe local/national regulations - edible fats and oils have a high specific biochemical oxygendemand; they are generally well biodegradable considering their low water solubility *4 - starch is not toxic for fish *5 13. Disposal considerations Waste from residues - incinerate in qualified installation with flue gas scrubbing - observe local/national regulations regarding waste disposal 14. Transport information Note - not classified by transport regulations 15. Other information Use - as a yellow colourant for food and pharmaceutical preparations Biological activity *1 referring to: β-carotene *2 referring to: Ascorbyl palmitate *3 referring to: Vitamin E *4 referring to: Vegetable oil *5 referring to: Starch *6 referring to: Gelatin - 1 I.U. (International Unit) of provitamin A corresponds to the activity of 0.60 µg purest crystalline β-carotene *1-1 R.E. (Retinol Equivalent) corresponds to 6 µg of purest β-carotene *1